Development and Validation of Novel Analytical Method for Empagliflozin and Metformin Hydrochloride in Bulk and Pharmaceutical Dosage Form by Four Different Simultaneous Estimation Approaches using UV Spectroscopy

Munde, Manojkumar K.; Kulkarni, Nilesh S.; Khiste, Rahul H.; Sen, Dhanya B.

doi:10.5958/0974-360x.2020.00228.0

Cited by 19 publications

(7 citation statements)

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“…Few other analytical methods were described for the simultaneous determination of LIG in combination with other antidiabetic agents using HPTLC (El-Kimary et al, 2016;Patel et al, 2020), UPLC/ UV (Ayoub, 2015;Vankalapati et al, 2021), and LC-MS/MS (Al Bratty et al, 2017;Rathod et al, 2020) methods, either in their pharmaceutical dosage form or in human plasma. In addition, other methods were reported for the determination of EMG either alone (Abdel-Ghany et al, 2018;Ayoub, Emam, et al, 2017;Manoel et al, 2021) or in combination with MEF Munde et al, 2020;Riaz et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

Application of experimental design in HPLC method optimization and robustness for the simultaneous determination of canagliflozin, empagliflozin, linagliptin, and metformin in tablet

Moussa

Mahrouse

Fawzy

2021

Biomedical Chromatography

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Gliflozins and gliptins represent two different pharmacological drug classes that exert different and potentially complementary glucose-lowering effect in patients with type II diabetes mellitus. A novel, selective, and sensitive HPLC method was developed for the determination of canagliflozin, empaglifozin, linagliptin, and metformin in pure form, in laboratory prepared mixtures, and in pharmaceutical dosage form. Experimental design optimization was applied by using Plackett-Burman and face-centered composite designs to achieve the best resolution with minimum experimental trials. Three significant variables affecting optimization, namely buffer pH, percentage of methanol, and percentage of acetonitrile, were studied. Chromatographic separation was achieved using an Agilent Eclipse C 8 column, and column temperature was kept at 45 C. The mobile phase was composed of dipotassium hydrogen phosphate buffer (0.05 M, adjusted to pH 6 using o-phosphoric acid):acetonitrile:methanol (50:25:25, v/v/v) at a flow rate of 1.5 mL/min. Sharp and wellresolved peaks of the cited drugs were obtained. The method was fully validated in terms of linearity, accuracy, precision, selectivity and robustness in agreement with the International Council of Harmonization (ICH) guidelines Q2 (R1). Satisfactory results were obtained by the analysis of tablets through applying the developed method. Therefore, it could be performed for the analysis of the cited drugs in quality control laboratories.

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Section: Introductionmentioning

confidence: 99%

Application of experimental design in HPLC method optimization and robustness for the simultaneous determination of canagliflozin, empagliflozin, linagliptin, and metformin in tablet

Moussa

Mahrouse

Fawzy

2021

Biomedical Chromatography

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“…31,35 Limit of Detection and Limit of Quantitation Correspondingly, LoD and LoQ of CGF were found 2.38 and 7.24 µg/mL, which demonstrated enormous sensitivity of the spectroscopy analytical method. [39][40][41]…”

Section: Robustnessmentioning

confidence: 99%

Preformulation and UV-Spectrophotometric Analytical Method Validation Studies for Assessment of Canagliflozin

Shukla¹,

Sharma²,

Singh³

et al. 2022

IJPQA

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>The objectives of the present investigation were the physicochemical examination of canagliflozin to authenticate the drug’s characteristics and validation of straightforward and rapid ultraviolet-spectroscopy technique for evaluation of canagliflozin in phosphate buffer, pH 6.8. X-ray diffraction study revealed numerous peaks i.e. 11.41, 16.35, 16.5, 16.65, 18.53, 18.58, 19.55, 20.11, 20.46, 20.71, 21.62, 23.96, 24.17, 24.77, 26.5, 27.08, 27.68, 28.22, 28.73 and 32.6 at °2θ which demonstrated extremely crystalline character of drug. The regression equation for the standard plot was Y = 0.01957X + 0.036, and correlation coefficient was 0.9936. The method was found linear as indicated by correlation coefficient values of 0.9933, 0.9938, and 0.9943 for three consecutive standard plots. The average recovery of Canagliflozin was found to be 100.033% which was inside the prerequisite specification of the range 98 to 102%. The percentage relative standard deviation for repeatability, inter-day precision, intermediate precision, and robustness was less than 2%. The limit of detection (LoD) for Canagliflozin was 2.38 μg/mL, and the limit of quantitation was 7.24 μg/mL, which established the sensitivity of the UV-spectroscopy analytical method. In conclusion, the validation parameters like linearity, accuracy, repeatability, inter-day precision, intermediate precision, robustness, and sensitivity were found acceptable for the UV-spectroscopy analytical technique for analysis of Canagliflozin.

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“…Various approaches were published in the literature for the simultaneous measurement of CAN and MET utilizing spectrophotometric [13][14][15] and high-performance liquid chromatographic (HPLC) [16][17][18][19][20][21] methods. While, EMP and MET were investigated using spectrophotometric [22][23][24][25][26][27] and chromatographic [20,21,[28][29][30][31][32][33][34][35] methods in pure and pharmaceutical form. Few published researches have discussed the simultaneous determination of the studied drugs with MEL [36][37][38][39][40][41][42].…”

Section: Introductionmentioning

confidence: 99%

Valuation of environmental influence of recently invented high‐performance liquid chromatographic method for hypoglycemic mixtures of gliflozins and metformin in the presence of melamine impurities: Application of molecular modeling simulation approach

Fawzy

Said

2023

J of Separation Science

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Molecular modeling is the science of representing molecular structures numerically and simulating their behavior with the equations of quantum and classical physics. Coupling molecular modeling and simulation with chromatographic resolution for pharmaceutical products constitutes a new technique in pharmaceutical analysis. An innovative high-performance liquid chromatographic (HPLC) methodology was developed for the quantification of metformin hydrochloride (MET), empagliflozin (EMP), and canagliflozin (CAN) in bulk, laboratory-developed combinations, pharmaceutical tablets, and in the presence of melamine. Chromatographic separation was accomplished using a Symmetry column with 0.03 M potassium dihydrogen phosphate buffer and 0.02 M heptane sulphonic acid: acetonitrile as the mobile phase. Molecular modeling using molecular operating environment software was applied to properly select the stationary phase suitable for the developed HPLC method. Additionally, molecular modeling estimates and validates binding between the studied analytes and the stationary phase to clarify and explain the chromatographic separation and elution order. In accordance with the International Conference of Harmonization recommendations, the method was validated in terms of linearity, accuracy, precision, and selectivity. The linearity ranges (μg/ml) were 200-1500 (MET), 2-15 (EMP), and 20-150 (CAN) and the limit of detection values were in the ranges of 0.17-54.58 μg/ml. Analysis of pharmaceutical tablets using the suggested approach yielded satisfactory outcomes. As a result, it might be used in quality control laboratories to analyze the aforementioned medications.

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Development and Validation of Novel Analytical Method for Empagliflozin and Metformin Hydrochloride in Bulk and Pharmaceutical Dosage Form by Four Different Simultaneous Estimation Approaches using UV Spectroscopy

Cited by 19 publications

References 0 publications

Application of experimental design in HPLC method optimization and robustness for the simultaneous determination of canagliflozin, empagliflozin, linagliptin, and metformin in tablet

Application of experimental design in HPLC method optimization and robustness for the simultaneous determination of canagliflozin, empagliflozin, linagliptin, and metformin in tablet

Preformulation and UV-Spectrophotometric Analytical Method Validation Studies for Assessment of Canagliflozin

Valuation of environmental influence of recently invented high‐performance liquid chromatographic method for hypoglycemic mixtures of gliflozins and metformin in the presence of melamine impurities: Application of molecular modeling simulation approach

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